IRINOTECAN EBEWE

מדינה: אוסטרליה

שפה: אנגלית

מקור: Department of Health (Therapeutic Goods Administration)

מרכיב פעיל:

Irinotecan hydrochloride

זמין מ:

Sandoz Pty Ltd

סיווג:

Medicine Registered

עלון מידע

 
Irinotecan 
Ebewe 
  Irinotecan 
Ebewe_CMI_v2_25072011.doc 

Page 1 of 5 

IRINOTECAN EBEWE 
irinotecan hydrochlori
de

CONSUMER MEDICINE INFORMATION 
WHAT IS IN THIS LEAFLET 
This leaflet answers some 
common questions about 
Irinotecan Ebewe. 
It does not contain all the 
available information.  It does 
not take the place of talking to 
your doctor or pharmacist. 
All medicines have benefits 
and risks. Your doctor has 
weighed the risks of you taking 
Irinotecan against the benefits 
this medicine is expected to 
have for you.  
IF YOU HAVE ANY CONCERNS 
ABOUT TAKING THIS MEDICINE, 
ASK YOUR DOCTOR OR 
PHARMACIST. 
KEEP THIS LEAFLET 
YOU MAY NEED TO READ IT 
AGAIN. 
It is important to remember 
that Irinotecan Ebewe is a 
PRESCRIPTION ONLY 
MEDICINE. 
Irinotecan Ebewe will only be 
given to you by specially 
trained personnel in a hospital 
environment. 
WHAT IRINOTECAN 
EBEWE IS USED FOR 
Irinotecan Ebewe belongs to 
the group of medicines called 
antineoplastics or cytotoxic 
medicines. 

Irinotecan Ebewe is used to 
treat bowel cancer which has 
spread to other parts of the 
body. Cancer which has spread 
cannot be treated by surgery 
alone and one of the options in 
this situation is treatment with 
an anticancer medicine, known 
as chemotherapy. 

Irinotecan Ebewe may be used 
once spread of cancer beyond 
the bowel is first diagnosed. At 
this time Irinotecan Ebewe will 
be given in combination with 
other anticancer medicines. 
Alternatively, Irinotecan 
Ebewe is used alone when the 
cancer has not responded or 
has returned after initial 
treatment. 

ASK YOUR DOCTOR IF YOU HAVE 
ANY QUESTIONS ABOUT WHY 
IRINOTECAN EBEWE HAS BEEN 
PRESCRIBED FOR YOU.  

Your doctor may have 
prescribed it for another 
purpose. 

BEFORE YOU ARE GIVEN 
IRINOTECAN EBEWE 
_WHEN YOU MUST NOT BE GIVEN _
_THIS MEDICINE: _
YOU MUST NOT BE GIVEN THIS 
MEDICINE IF YOU HAVE HAD AN 
ALLERGIC REACTI

מאפייני מוצר

_Product Information  _
_ _
_Page _ _1 _                               

_Irinotecan Ebewe 40mg/2mL; 100mg/5mL; 150mg/7.5mL; 300mg/15mL;
500mg/25mL injection _
_06/2011 _

_Sandoz Pty Ltd_  

Version 
05 

PRODUCT INFORMATION 
IRINOTECAN EBEWE
®  
40MG/2ML, 100MG/5ML, 150MG/7.5ML, 300MG/15ML, 500MG/25ML 
CONCENTRATED INJECTION  
NAME OF THE MEDICINE 
Irinotecan hydrochloride 20mg/mL concentrated injection vial 

CAS number: 136572-09-3  
DESCRIPTION 
Irinotecan hydrochloride is a semisynthetic derivative of
camptothecin, an alkaloid extract 
from plants such as _Camptotheca acuminata_. It is a pale yellow to
yellow crystalline powder. 
Irinotecan hydrochloride is slightly soluble in water and organic
solvents.  
Molecular formula: C
33
H
38
N
4
O
6
.HCl . 3H
2
O 
Molecular weight: 677.19 g/mol 
Irinotecan Ebewe concentrated injection is supplied as a sterile,
light yellow aqueous solution 
with pH 3.0-3.8. It is intended for dilution with 5% Glucose
Injection or 0.9% Sodium 
Chloride Injection prior to infusion. In addition to irinotecan
hydrochloride, the ingredients 
are sorbitol, lactic acid, sodium hydroxide and water for injections.

PHARMACOLOGY 
CLASS OF MEDICINE 
Antineoplastic.  
Irinotecan hydrochloride is a derivative of camptothecin.
Camptothecins interact specifically 
with the enzyme topoisomerase I which relieves torsional strain in
DNA by inducing 
reversible single-strand breaks. Irinotecan hydrochloride and its
active metabolite SN-38 bind 
_Product Information  _
_ _
_Page _ _2 _                               

_Irinotecan Ebewe 40mg/2mL; 100mg/5mL; 150mg/7.5mL; 300mg/15mL;
500mg/25mL injection _
_06/2011 _

_Sandoz Pty Ltd_  

Version 
05 

to the topoisomerase I - DNA complex and prevent religation of these
single-strand breaks. 
Current research suggests that the cytotoxicity of irinotecan
hydrochloride is due to double-
strand DN